FDA Revokes Recommendation For Breast Cancer Drug Avastin

The Food and Drug Administration announced today (Dec. 16) that it is recommending that Avastin (bevacizumab) not be used to treat breast cancer.

The FDA said the drug's benefits are outweighed by its health risks. The drug received accelerated approval from the FDA in 2008 for use in treating breast cancer along with chemotherapy. However, four studies found that it did not increase survival of patients with advanced breast cancer patients, nor did it slow the spread of the cancer, according to the agency.

The four clinical trials, which test the effectiveness and safety of a substance before it can become an approved drug, did find a link between the drug and severe high blood pressure, bleeding and hemorrhage and the development of holes in the lining that separates the right and left nostrils, as well as perforations in the stomach and intestines, the FDA said. The drug is also associated with heart attack and heart failure.

"After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed based on evidence from four independent studies," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

In July of this year, an independent advisory committee voted to revoke approval of Avastin as a treatment for breast cancer after reviewing data from previous studies.

Woodcock said that none of the studies demonstrated that patients who took Avastin lived longer or experienced a significant increase in serious side effects. But the limited effects of the drug, combined with its potential risks, led the FDA to make the decision to revoke its approval of the drug to treat breast cancer, she said.

"The results of these studies are disappointing," Woodcock said. "We encourage the company to conduct additional research to identify if there may be select groups of patients who might benefit from this drug."

However, the FDA announcement does not mean the drug will be removed from the market or have any impact on its use to treat breast cancer. The announcement also has no effect on the drug's use to treat colon, kidney, lung and brain cancers, according to the FDA.

Doctors who treat their patients with Avastin for breast cancer should use their own judgment for whether their patients should continue using the drug, the FDA said.

The FDA has informed Genentech, Avastin's manufacturer, of its recommendation to withdraw approval to market the drug for breast-cancer treatment purposes. Genentech has the opportunity to request a hearing to contest the recommendation; if it does not request the hearing in 15 days, the FDA will begin the process to remove the breast-cancer indication from the drug.

Breast-cancer patient advocacy group Susan G. Komen for the Cure and the Ovarian Cancer National Alliance issued a statement in August urging the FDA not to revoke its recommendation of Avastin for breast cancer treatment.

They said that even though FDA approval is not necessary for a doctor to legally prescribe Avastin to a patient, insurance companies could choose not to cover the drug.

Pass it on: The FDA has begun the process to revoke the approval of Avastin (bevacizumab) to be used to treat breast cancer.

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